Job Summary

The Quality Control Data Reviewer supports Quality Control laboratory operations by making sure analytical data and reports are accurate, complete, traceable, and compliant before results are released. The role verifies that testing was performed according to validated methods, approved specifications, protocols, SOPs, and cGMP requirements. It also verifies that data meets ALCOA+ data integrity principles. The Data Reviewer performs second-person review of chromatographic and other analytical data across paper and electronic systems. They identify discrepancies, errors, and compliance risks and escalate them, and they serve as the laboratory’s subject matter expert on data review practices. 

Core Responsibilities

• Review Quality Control data and analytical reports, including release testing, stability testing, and analytical method validation, for compliance with approved specifications, written procedures, GMP requirements, and applicable compendial monographs in a timely manner.
• Review chromatographic data, laboratory notebooks, associated documentation, and sample results for scientific soundness, accuracy, completeness, traceability, appropriate data interpretation, and accurate representation of the final reported results.
• Review equipment and instrument logbooks to ensure entries are accurate, complete, contemporaneous, and compliant with applicable procedures.
• Verify appropriate audit trail records as part of the data review process and assess electronic data for completeness, traceability, and compliance with applicable data integrity requirements consistent with 21 CFR Part 11
• Document and communicate data review findings, including deficiencies, discrepancies, or observations identified within analytical data, supporting documentation, or reports, in a clear, concise, and timely manner.
• Conduct and document laboratory investigations, including evaluation of data discrepancies and laboratory events, with support and oversight from the Laboratory Manager, as applicable.
• Promptly report identified non-conformances, data integrity concerns, or other potential compliance issues to Laboratory Management.
• Review and revise applicable SOPs and laboratory procedures to support continuous improvement, enhance laboratory efficiency, and ensure alignment with current laboratory practices and regulatory requirements.
• Perform document control activities supporting routine laboratory operations, including issuance and control of laboratory notebooks and logbooks, document reconciliation, archival of completed records, and maintenance of controlled laboratory documentation.
• Serve as a Subject Matter Expert (SME) for Quality Control data review processes and provide guidance and support to laboratory personnel regarding data review expectations and applicable procedures.
• Support continuous improvement of laboratory data review practices and processes while maintaining compliance with applicable GMP and data integrity requirements.
• Adhere to applicable laboratory safety requirements, OSHA regulations, and established safety procedures.
• Perform other duties and responsibilities as assigned.

Qualifications & Requirements

• Minimum BS in Chemistry, Biology, Pharmaceutical or related sciences
• At least four to five years of laboratory experience preferably in pharmaceutical, chemical or food laboratory

• Previous data review experience is preferred with Chromeleon, HPLC, GC, FTIR etc.
• Knowledge of current United States Pharmacopeia and National Formulary (USP-NF)
• Working experience in Deviations, CAPA and out-of-specification (OOS) investigations utilizing root cause analysis tools
• Basic understanding of Quality Management System i.e. Veeva
• Must be able to work independently with limited direct supervision
• Good written and verbal communication skills
• Must be computer literate, working knowledge of the basic hardware, software, internet including word and excel
• Must be able to maintain a safe working environment and follow safety procedures

Position Type

• On-Site

Travel

• Up to 10%